Trials Expected to Produce Preliminary Data Mid-2005
DENVER, Nov. 30 /PRNewswire-FirstCall/ -- Myogen, Inc. (Nasdaq: MYOG), a
biopharmaceutical company focused on the discovery, development and
commercialization of small molecule therapeutics for the treatment of
cardiovascular disorders, today announced the completion of the treatment
phase for ESSENTIAL I & II, the Company's two pivotal Phase III trials of low-
dose enoximone capsules in patients with advanced chronic heart failure (CHF).
"The completion of the treatment phase of the ESSENTIAL trials is an
important milestone for Myogen," said J. William Freytag, President and Chief
Executive Officer of Myogen. "The two trials enrolled 1,854 patients at 211
trial sites in 16 countries around the world. The mean study follow-up period
now exceeds 19 months. As of November 30th, a sufficient number of primary
endpoint events were estimated to have occurred to fulfill the statistical
power requirements for the first primary endpoint, allowing us to terminate
the trials. We will now focus on completing final visits for patients and
collecting data so we can lock the trials' database as soon as possible. We
project that this will occur around mid-year 2005."
About the ESSENTIAL TRIALS
ESSENTIAL I & II are randomized, double-blind, placebo-controlled trials
conducted in North and South America (ESSENTIAL I) and in Western and Eastern
Europe (ESSENTIAL II). ESSENTIAL I & II are identical trials differing only
in the geographic location of the study sites. Patient enrollment for both
trials began in the first half of 2002.
The ESSENTIAL trials were designed to evaluate the safety and efficacy of
low-dose enoximone capsules in patients with NYHA Class III and IV CHF.
Patients were randomized in a 1:1 ratio to receive either 25 mg of enoximone
or placebo, administered three times a day (t.i.d.). In the absence of
contraindications after two weeks of treatment, all patients weighing greater
than 50 kg received 50 mg of enoximone or placebo t.i.d.
"Given the advanced nature of their disease, these patients have a high
likelihood of death or hospitalization due to cardiovascular causes," said Dr.
Michael Gerber, Senior Vice President of Clinical Development and Regulatory
Affairs for Myogen. "The goal of these trials was to demonstrate that the
addition of low-dose enoximone to standard guideline therapy including beta-
blockers would reduce the likelihood of re-hospitalization or mortality and
improve exercise capacity and quality of life for these patients."
The ESSENTIAL trials have three primary endpoints: (1) time from
randomization to first cardiovascular hospitalization or all-cause mortality,
(2) submaximal exercise capacity (as measured by six-minute walk distance),
and (3) patient global assessment. Data from both trials will be pooled for
the analysis of the first primary endpoint of cardiovascular hospitalization
or all-cause mortality. The second and third primary endpoints will be
analyzed within each individual trial.
About Chronic Heart Failure
CHF generally occurs in patients with a long history of uncontrolled high
blood pressure or in patients that have suffered a heart attack or some other
heart-damaging event. It is estimated that half of all patients with this
disorder die within five years of diagnosis. CHF is one of the largest health
problems in the developed world, with annual direct and indirect healthcare
costs in the United States alone exceeding $24 billion. In the United States,
approximately five million patients are afflicted with chronic heart failure,
with an additional 550,000 new cases reported each year. CHF therapeutics are
a $14 billion market that is expected to grow to more than $22 billion in
2008.
As patients enter the advanced stages of CHF, Classes III and IV, their
cardiac function deteriorates, leading to an accumulation of fluid in the
lungs, referred to as pulmonary congestion. Eventually, pulmonary congestion
and the resulting breathlessness and fatigue reach a critical point referred
to as acute decompensated heart failure. At this point the patient must be
hospitalized and treated with i.v. diuretics, vasodilators and positive
inotropes such as dobutamine, milrinone or Perfan(R) I.V., all of which serve
to increase the efficiency of the circulatory system, providing symptomatic
relief. After stabilization and discharge from the hospital, patients often
decompensate again within months and must be readmitted to the hospital for
another round of i.v. treatment. As their disease progresses, the frequency
of decompensation and hospitalization increases until patients succumb to
their disease or must be maintained on continuous or intermittent treatment
with these i.v. agents.
About Enoximone
Enoximone is a small organic molecule that exhibits highly selective
inhibition of type-III phosphodiesterase, or PDE-III, an enzyme that is
present in the heart and plays an important regulatory role in cardiac
function. PDE-III inhibitors block the action of this enzyme, increasing the
force of contraction of the heart and increasing the rate of relaxation,
thereby increasing cardiac output. Compounds that increase the force of
contraction of the heart, like enoximone, are referred to as positive
inotropes. Enoximone also causes vasodilation, an increase in the diameter of
blood vessels, through its effects on smooth muscle cells that surround blood
vessels, which results in lower pressure against which the heart must pump.
Positive inotropy and vasodilation can both be therapeutically useful in the
treatment of heart failure.
About Myogen
Myogen is a biopharmaceutical company focused on the discovery,
development and commercialization of small molecule therapeutics for the
treatment of cardiovascular disorders. Myogen currently markets one product
in Europe (Perfan(R) I.V.) for the treatment of acute decompensated heart
failure and has three product candidates in late-stage clinical development:
enoximone capsules for the treatment of CHF, ambrisentan for the treatment of
pulmonary arterial hypertension and darusentan for the treatment of resistant
hypertension. The Company, in conjunction with Novartis, also conducts a
target and drug discovery research program focused on the development of
disease-modifying drugs for the treatment of CHF and related cardiovascular
disorders. Please visit Myogen's website at http://www.myogen.com.
Safe Harbor Statement
This press release contains forward-looking statements that involve
significant risks and uncertainties, including those discussed in this release
and others that can be found in the "Risk Factors" section of Myogen's Annual
Report on Form 10-K for the year ended December 31, 2003, Myogen's Form S-3
filed on October 29, 2004 and in Myogen's periodic reports on Form 10-Q and
Form 8-K. Myogen is providing this information as of the date of this release
and does not undertake any obligation to update any forward-looking statements
contained in this document as a result of new information, future events or
otherwise.
The Company cautions investors not to place undue reliance on the forward-
looking statements contained in this press release. No forward-looking
statement can be guaranteed and actual events and results may differ
materially from those projected. If the Company's product candidates,
including enoximone, do not meet the safety or efficacy endpoints in clinical
evaluations, they will not receive regulatory approval and the Company will
not be able to market them. Even if the Company's product candidates meet the
safety and efficacy endpoints, regulatory authorities may not approve them, or
the Company may face post-approval problems that require the withdrawal of its
product from the market. The Company's results may be affected by its
effectiveness at managing its financial resources, its ability to successfully
develop and market current and new products, difficulties or delays in its
clinical trials, difficulties or delays in manufacturing its products, and
regulatory developments involving current and future products. The Company
may not be able to analyze the data from the ESSENTIAL trials in time to
publicly release and report top-line results by mid-year 2005. Results from
earlier clinical trials are not necessarily predictive of future clinical
results. If the Company is unable to raise additional capital when required
or on acceptable terms, it may have to significantly delay, scale back or
discontinue one or more of its drug development or discovery research
programs. Myogen is at an early stage of development and may not ever have
any products that generate significant revenue.
SOURCE Myogen, Inc.
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Related links:
http://www.myogen.com
CONTACT:
Derek K. Cole, Director, Investor Relations,
+1-303-464-3986, derek.cole@myogen.com, or Joseph L. Turner,
Chief Financial Officer, +1-303-464-5222, joe.turner@myogen.com,
both of Myogen, Inc.
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